Not recruiting

Study on Long-Term Safety and Efficacy of ARO-APOC3 for Adults with Mixed Dyslipidemia

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the long-term safety and effectiveness of a treatment called ARO-APOC3 in adults with a condition known as dyslipidemia. Dyslipidemia is a medical condition where there is an abnormal amount of lipids, such as cholesterol and triglycerides, in the blood. The treatment being tested, ARO-APOC3, is a solution for injection that contains a special type of molecule designed to target and reduce a protein called apolipoprotein C-III, which is involved in lipid metabolism.

The purpose of this study is to evaluate how safe and effective ARO-APOC3 is when used over a long period. Participants in the study will receive the treatment through subcutaneous injections, which means the solution is injected under the skin. The study will monitor participants for any side effects and measure changes in various blood lipid levels, including triglycerides, non-high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol, among others.

This study is an extension of a previous trial, meaning it continues to observe participants who have already completed an earlier phase of treatment. The trial aims to provide more information on how ARO-APOC3 affects lipid levels in the blood over time and to ensure that it remains safe for long-term use. Participants will be closely monitored throughout the study to gather comprehensive data on the treatment's impact on their health.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Participation begins after completing a prior 48-week study treatment period.
Eligibility requires being an adult aged 18 or older, not pregnant or lactating, and having provided written consent.
Step 2
Treatment administration
The medication used is called ARO-APOC3, which is a solution for injection.
It is administered through a subcutaneous injection, meaning it is injected under the skin.
The treatment aims to evaluate the long-term safety and effectiveness of ARO-APOC3 in managing mixed dyslipidemia.
Step 3
Monitoring and evaluation
The primary focus is on observing any treatment-emergent adverse events (TEAEs).
Secondary evaluations include changes in various blood lipid levels, such as triglycerides, apolipoprotein C-III, non-high-density lipoprotein cholesterol, high-density lipoprotein cholesterol, total apolipoprotein B, and low-density lipoprotein cholesterol.
Step 4
Study duration
The study is expected to conclude by September 26, 2025.
The recruitment for the study began on July 7, 2022.

Who can join the trial?

4 criteria

Adults who are **18 years or older** can participate.
Participants must be **nonpregnant** and **nonlactating** (not breastfeeding) and should not plan to become pregnant during the study.
Participants must be able and willing to provide **written informed consent** before any study-specific procedures are done. This means they agree to participate and understand what the study involves.
Participants must have completed the **48-week study treatment period** in the previous related study.

Who cannot join the trial?

10 criteria

Individuals with certain health conditions that might interfere with the study.
People who are currently taking medications that could affect the study results.
Participants who have had a recent major surgery or are planning to have one soon.
Women who are pregnant or breastfeeding.
Individuals with a history of allergic reactions to similar treatments.
People with severe liver or kidney problems.
Participants who are part of another clinical trial.
Individuals with uncontrolled high blood pressure.
People with certain heart conditions that are not stable.
Participants who have a history of substance abuse.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Albert Schweitzer Ziekenhuis
Verified
Dordrecht, The Netherlands
Amsterdam UMC
Responsive
Amsterdam, The Netherlands
Centrum Medyczne Medyk Sp. z o.o.
Verified
Rzeszow, Poland

Trial locations

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Investigated drugs

ARO-APOC3 is a medication being studied for its potential to help manage dyslipidemia, a condition characterized by abnormal levels of lipids in the blood. This medication is designed to target and reduce the production of a specific protein involved in lipid metabolism, which may help lower cholesterol and triglyceride levels. The trial aims to assess the long-term safety and effectiveness of this treatment in adults with mixed dyslipidemia.

Synthetic Double-Stranded Sirna Oligonucleotide Directed Against Apolipoprotein C-Iii Mrna And Covalently Linked To A Ligand Containing Three N-Acetylgalactosamine Residues

What is already known about the treatment

ARO-APOC3 – ARO-APOC3 is administered as an injection, typically under the skin. It is currently being studied in clinical trials to assess its long-term safety and effectiveness for treating mixed dyslipidemia, a condition characterized by abnormal levels of lipids in the blood. The medication works by targeting and reducing the production of a protein called apolipoprotein C-III, which plays a role in lipid metabolism. ARO-APOC3 is classified as an RNA interference therapeutic, which means it uses small RNA molecules to interfere with the expression of specific genes involved in lipid regulation.

Investigated diseases

Mixed Dyslipidemia – Mixed dyslipidemia is a condition characterized by abnormal levels of lipids in the blood, including high levels of low-density lipoprotein (LDL) cholesterol, triglycerides, and low levels of high-density lipoprotein (HDL) cholesterol. This imbalance can lead to the buildup of fatty deposits in the arteries, increasing the risk of cardiovascular diseases. The condition often progresses silently, with no obvious symptoms, until significant arterial damage occurs. Over time, the persistent imbalance in lipid levels can contribute to the development of atherosclerosis, where arteries become narrowed and hardened. This can eventually lead to complications such as heart attacks or strokes if not managed. Mixed dyslipidemia is often associated with lifestyle factors, genetic predisposition, or other underlying health conditions.